The Human Medicines (Amendment) Regulations 2019

Insertion of regulation 94A (offences relating to Commission Regulation 2016/161)

This section has no associated Explanatory Memorandum

8.  After regulation 94 (failure to submit report to EMA), insert—

Offences relating to the safety features appearing on the packaging of medicinal products

Offences relating to Commission Regulation 2016/161

94A.(1) The holder of a marketing authorisation or parallel import licence, or a parallel distributor, is guilty of an offence if the holder fails to comply with a requirement or obligation contained in a provision of Commission Regulation 2016/161 listed in paragraph (2).

(2) The provisions mentioned in paragraph (1) are—

(a)Article 33 (uploading of information in the repositories system);

(b)Article 40 (products recalled, withdrawn or stolen);

(c)Article 41 (products to be supplied as free samples); and

(d)Article 42 (removal of unique identifiers from the repositories system).

(3) In this regulation “parallel distributor” means a person who imports from another EEA state a product which has been granted a marketing authorisation under Regulation (EC) No 726/2004 and in relation to which that person is not the holder of marketing authorisation, Article 126a authorisation, certificate of registration or a traditional herbal registration..